ISSUE: The FDA has reviewed information that suggests unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects. Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has traveled to other parts of the body. This can cause vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures.

While unintentional injections into blood vessels may occur with injection sites anywhere on the face, the FDA’s review of literature and adverse event reports submitted to the FDA identifies certain injection locations where blood vessel blockage have been reported more often. These sites include the skin between the eyebrows and nose (glabella), in and around the nose, forehead, and around the eyes (periorbital region).

FDA is working with manufacturers to update their labeling. The requests asks that the labeling include additional warnings, precautions, and other statements about the risk of unintentional injection into blood vessels, consistent with the recommendations in this communication, so that both health care providers and patients would have a better understanding of the risks.

BACKGROUND: Soft tissue fillers, also called dermal fillers, injectable facial implants, or wrinkle fillers, can create a smoother or fuller appearance of the face. They are FDA-approved to reduce the appearance of wrinkles or to augment lips or cheeks.

RECOMMENDATIONS:
•Do not inject soft tissue fillers if you do not have the appropriate training or experience.
•Make sure that you are familiar with the anatomy at and around the site of injection, keeping in mind that blood vessel anatomy can vary among patients.
•Before injection, thoroughly inform the patient of all risks of the procedure and the specific product you intend to use.
•Note that the approved indications for use of soft tissue fillers vary depending on the product. The FDA may not have reviewed use of soft tissue fillers in some locations in the body.
•Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary.
•Know the signs and symptoms associated with injection into blood vessels, and have an updated plan detailing how you plan to treat the patient if this should this occur. This may include on-site treatment and/or immediate referral to another health care provider for treatment.
•Immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel, such as changes in vision, signs of a stroke, white appearance (or blanching) of the skin, or unusual pain during or shortly after the procedure.
•Tell patients that they should seek immediate medical attention after the procedure if they experience signs and symptoms associated with injection into a blood vessel.
•Educate health care facility employees on how to quickly assist patients that report signs and symptoms of filler complications. They must understand how to instruct the patient to receive appropriate medical care.
•Report to the FDA and the manufacturer if you become aware of a patient experiencing an adverse event associated with unintentional injection of soft tissue filler into a blood vessel.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

•Complete and submit the report Online: www.fda.gov/MedWatch/report
•Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
•Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.